| TGA Action ID |
RC-2026-RN-00161-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica IM Active-B12 (Holotranscobalamin) (AB12) Assay (100 Test). An in vitro diagnostic medical device (IVD).
Test Code: AB12
Material Number: 10733001
Kit Lot Numbers: 62765105, 62759108, 65207111
Expiry Dates: 31-Mar-2026, 17-Jul-2026, 11-Nov-2026 |
| ARTG Number |
175700 |
| Unique Device Identifier (UDI) |
00630414245720 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Siemens Healthineers has confirmed through the investigation of customer complaints that the Atellica IM Active-B12 (Holotranscobalamin) (AB12) Assay kit lots may be impacted by the following problem:
Patient Results Bias: For Atellica IM AB12 Assay kit lots ending in 105, 108, and 111, patient results may demonstrate negative and positive bias. These patient biases may not be detected by Atellica IM Active-B12 Quality Control (AB12 QC).
No patient harm has resulted due to this problem. |
| Instructions for Customers/Users |
o For Atellica IM AB12 kit lots ending in 105, 108, and 111: discontinue use immediately and discard the affected kit lot(s).
o Review your inventory to determine your laboratory’s replacement needs and provide information to Siemens Healthineers. |
| Action Commencement Date |
3/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care |